Wednesday, November 09, 2011

Only in the UK & Down Under? Pity! (Musings on hemovigilance)

The UK's Serious Hazards of Transfusion (SHOT) report for 2010 became available in the summer, and I thought a blog on its key findings was in order before 2011 ends.

As I got into it, I realized that something was amiss. Such reports simply do not exist in my own country (Canada) nor the USA, with which we share the longest border in the world between any two countries.

The blog's title comes from an old, iconic Red Rose tea commercial in Canada. Only in the UK and Down Under refers to the English-speaking world.

As most transfusion professionals know, SHOT, established in 1996, is the mother of all hemovigilance schemes and an exemplary example of transparency for blood transfusion systems worldwide.

It's also worth noting that blood transfusion in the developed world is safer than ever. When you examine hemovigilance reports you realize that Pogo was right. We have met the enemy and he is us.

Despite improved screening to prevent transfusion-transmitted diseases and the tainted blood tragedies of the 80s and 90s, and despite the massive effort to implement quality systems, we humans remain the challenge. The education and training of all health personnel is the single most crucial QSE.

SHOT 2010

Like all hemovigilance schemes, SHOT IS voluntary and gathers and investigates reports of adverse events, near misses and physiological reactions that may be linked to transfusion. Investigation of reported cases generally concludes, based on available evidence and its quality, that the adverse event (interpretations are mine)
  • Had little if anything to do with transfusion (no evidence)
  • Possibly resulted from transfusion (low-level evidence)
  • Likely resulted from transfusion (good evidence but inconclusive)
  • Definitely resulted from transfusion (strong evidence)
So, what are the highlights of SHOT's 2010 report?


The worst first. SHOT 2010 includes 13 transfusion-related deaths, 3 in which transfusion directly and solely ('definitely') contributed. The putative contributory causes include:

  • TACO: 6 (1 definitely, 3 likely, 2 possibly)
  • ATR (acute transfusion reaction)*: 3 (1 definitely, 2 possibly)
  • HTR (hemolytic transfusion reaction): 1 (definitely)
  • Under-transfusion: 1 (possibly)
  • Delayed transfusion: 1 (possibly)
  • TRALI: 1 (possibly)

* ATR: Acute reactions occurring up to 24 hrs post-transfusion, excluding cases due to IBCT (incorrect blood component transfused), HTR, TRALI, TACO, TAD (transfusion-associated dyspnea) and bacterial contamination.

As well there were 101 cases involving major morbidity, 57 of which were classified as acute transfusion reactions.


Classifying cases is complex since adverse events and errors can be classified along multiple lines. Overall, of the 1464 cases in SHOT 2010, most (88.8%) fell into these categories:
  • Acute transfusion reaction: 510 (34.8%)
  • Involving anti-D immune globulin (RhIg): 241 (16.5%)
  • Handling and storage errors: 239 (16.3%)
  • Incorrect blood component transfused: 200 (13.7%)
  • Inappropriate, unnecessary, under or delayed transfusion: 110 (7.5%)
Another way to look at incidents and cases is to assess if they originated in clinical areas or transfusion service laboratories. I encourage you to read these sections of the report, which contain many valuable tidbits, or 'learning points' as the report calls them. Two examples:

 Clinical: Lack of correct final identity check leads to an HTR (p. 21)
A patient with a haematemesis was in need of an urgent blood transfusion. The patient’s wristband was contaminated with blood and could not be read, and as a consequence the electronic bedside checking system was not used. The compatibility form filed in the patient’s notes, which belonged to another patient, was used to provide the identifiers for collecting the blood. The patient, who was group O RhD positive, was transfused with >50 mL of A RhD positive red cells prior to the error being recognised. The patient was admitted to ITU with intravascular haemolysis and renal impairment. 
Laboratory: Cord blood group allocated to wrong computer record, resulting in delay in administration (p. 65)
A cord blood group was correctly tested as RhD positive, but the result was erroneously uploaded to the maternal record on the laboratory computer system by a shift BMS [lab technologist] who did not normally work in transfusion. The error was only spotted when the clinical area enquired as to why there was no cord group available and why the maternal group was now showing as RhD positive.
For fun: Related to incorrect blood components transfused, guess which area (clinical or laboratory) decreased its errors most compared to 2009. (Answer on p. 1 of the report)


Both Australia and New Zealand have active hemovigilance systems that publish detailed public reports.


Australia produced its first report in 2008. The 2010 report deals with transfusion errors and adverse events that occurred July 2008–June 2009. The Oz hemovigilance system is not as mature as the UK system (no system is, at least in the English-speaking world) but the clear reporting and detailed case studies make for fascinating reading.

New Zealand

The Kiwis produced their first report in 2005 and have a more advanced system than Australia's. For example, the NZ 2009 report includes antibodies involved in delayed hemolytic / serologic reactions and also donor adverse events.

For fun: Guess which two antibodies lead the delayed transfusion reaction list? (Answer on p. 24 of the report)

The USA's Biovigilance Network was initiated only in 2006 and, so far as I know, has yet to publish public reports similar to SHOT, although data for individual diseases such as Chagas are available to AABB members.
Of note, before 2006 the USA was one of the only developed countries in the world without a national hemovigilance program, just as it's one of the few without universal health care.


What about my own country? On paper we seem to have a national hemovigilance system called TTISS but upon closer examination TTISS appears to be smoke and mirrors.

For example, the last published TTISS report available on the PHAC website is the
What gives? Either we have a national hemovigilance system or we don't. Is it another case of phantom transfusion committees that meet now and then to document they exist but never really do anything of substance?

Did the federal government decrease PHAC money at some point, so that it could not implement original plans for the hemovigilance system? Did PHAC decide hemovigilance was low priority compared to other public health issues?

Who knows? It's never discussed. Everyone just pretends.

Whatever the reason, Canada's blood system leaders may pretend that the emperor has new clothes, but it seems that TTISS has no clothes, much like Hans Christian Andersen's emperor.

Provincial government blood coordinating offices have TTISS programs and routinely state on their websites
  • Data are disseminated regularly to stakeholders through TTISS Program Reports.
Really? The links go to the PHAC site with the most recent report the one for 2004-5. To call them 'reports' is farcical as they consist of an introduction and table of contents. Who is kidding who?


Kudos to the UK, Australia, and NZ governments and their respective blood systems for stepping up to the plate with hemovigilance.

But why do Canada and the USA lag behind when it comes to hemovigilance?

You can somewhat understand the USA situation. Unlike most countries in the developed world, it has a competitive, fragmented blood system involving multiple players.

As well, hemovigilance systems elsewhere are largely funded by governments, something some Americans on the right (or maybe even most Americans) equate with "socialized medicine" or worse, i.e., supported by delusionary 'commie pinkos' (big grin)

Still, the USA has a well developed blood system and it remains the richest country on earth. That its hemovigilance system is barely off the ground in 2011 is worrisome, if not to say pathetic.

But Canada's TTISS is inexplicable. Frankly, I'm embarrassed that we pretend to have a national hemovigilance system when we don't.

Maybe it's not that surprising. When it comes to hospital-based transfusion services, the feds have always employed smoke and mirrors.

In the early 2000s there was a big kerfuffle about government regulation of the blood system extending beyond blood suppliers to transfusion services. I even wrote about it:
At the time the TM community believed that CSA Standards applicable to transfusion services would become government regulations within approximately 2 years. That did not happen and has not happened yet, 7 years later.

We do not know why, but I suspect it's the government wanting to save money combined with a belief that transfusion service regulation is low priority, given that transfusion services must comply with standards to be accredited by provincial colleges of physicians and surgeons. This viewpoint may or may not be a valid argument.

But why the smoke and mirror pretence about hemovigilance? It's cheating. Makes me wonder what other deceptions our blood system leaders are conning us with.


Some golden oldies that seem to fit the federal government's modus operandi:
Will those responsible ever say "I'm sorry"? I doubt it.

15 Nov. 2011: Just read an editorial in the Dec. issue of the BBTS journal, Transfusion Medicine:
  • Roberts DJ. Public policy, blood safety and haemovigilance. Trans Med 2011; 21(6):357-8. Pub. online 14 Nov. 2011.
The editorial discusses the focus of the Dec. issue, i.e., SaBTO's recommendations on
  • accepting male blood donors who have had sex with men;
  • desirability and practicalities of obtaining formal consent for blood transfusion.
The author concludes:
"Both these recent decisions and the means to implement them depend directly or indirectly on a good quantitative analysis of the risk of blood transfusion. There could be no better illustration of the practical importance of reliable and comprehensive haemovigilance schemes. Establishing and maintaining such systems must be a priority for the development of safe and effective transfusion and transplantation services globally."
As usual, the opinions are mine alone. Comments are most welcome.

Further Reading

SHOT 2010 Educational Symposium (14 Oct. 2011):
"Transfusion - Are we over-reacting?" (Alison Watt, SHOT Operations Manager)
Stainsby D, et al. Serious hazards of transfusion: a decade of hemovigilance in the UK. Transfus Med Rev. 2006 Oct;20(4):273-82.
Global shift towards increased biovigilance surveillance system. (CMAJ 2010. DOI:10.1503/cmaj.109-3195).
Pilot projects lay foundation for national tissue surveillance and traceability system

Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice. 


  1. Anonymous8:45 PM

    Pat, thank you for opening the discussion on this vital topic. Many of us are passionate about transfusion safety and get agitated about the TTISS responsiveness gap. While we are proud that there's a nationwide system for 'standardized' reporting, the fact is we don't have a means of alerting transfusionists of current emerging issues except through more informal means (Transfusion lists? word of mouth? educational events?)
    And then there's TESS; At AABB last month those of us fortunate enough to attend discovered TESS was available for all Canadian hospitals -- who knew?

  2. Thanks for the feedback, Anonymous. Transfusion Error Surveillance System (TESS) seems to be another phantom project.

    From the PHAC website:

    "The pilot is expected to end in the spring of 2008 and participation of additional institutions is anticipated. Plans for the future expansion of TESS are still under development."

    Three and a half years and counting...